Breast Cancer Clinical Trial

AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine Therapy

Summary

The purpose of this study is to look at the effects that the study drug (OPC) has on AGE levels in patients with ER+ metastatic breast cancer.

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Full Description

AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if certain drug (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.

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Eligibility Criteria

Inclusion Criteria:

Must have ER+ breast cancer
Metastatic disease; protocol does allow for bone-only disease
Must be receiving endocrine therapy
Must have completed at last 2 months of current endocrine therapy prior to registration
Must have adequate hematologic, renal and hepatic function
Prior/concurrent radiation therapy is allowed
Prior chemotherapy is allowed, but last dose must have been at least 2 months prior to enrollment
May have diabetes, but must not be taking metformin
Must be able to swallow and retain oral medication
Performance status of 0-2
Treated stable brain metastases are allowed, as long as patient does not require steroids or anti-seizure medications
Must be informed of the investigational nature of this study and must have the ability to sign informed consent.

Exclusion Criteria:

Known allergy to grapes or grape seed
More than two prior endocrine therapy regimens for the treatment of metastatic ER+ breast cancer.
Concurrent use of restricted agents outlined in section 4.5.
History of alcohol abuse within 2 years of registration.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT03092635

Recruitment Status:

Terminated

Sponsor:

Medical University of South Carolina

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There is 1 Location for this study

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Medical University of South Carolina
Charleston South Carolina, 29425, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT03092635

Recruitment Status:

Terminated

Sponsor:


Medical University of South Carolina

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